The following data is part of a premarket notification filed by Bioshield, Inc. with the FDA for Disposable Medical Gowns.
| Device ID | K891820 |
| 510k Number | K891820 |
| Device Name: | DISPOSABLE MEDICAL GOWNS |
| Classification | Gown, Patient |
| Applicant | BIOSHIELD, INC. 2900 STANDIFORD AVE. SUITE 16-B Modesto, CA 95350 |
| Contact | Jim Jacobson |
| Correspondent | Jim Jacobson BIOSHIELD, INC. 2900 STANDIFORD AVE. SUITE 16-B Modesto, CA 95350 |
| Product Code | FYB |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-07-24 |